politics

Scandal Is Worse Than You Think

The EpiPen Scandal Is Worse Than You Think: What You’re Not Being Told

TheAntiMedia.org, Aug 27, 2016

The EpiPen is a useful device for individuals who suffer from severe allergies. News broke that Mylan, the sole maker of the autoinjector “pens” in America, had hiked the prices of its products from $57 each in 2007 to $600 for a package of two in 2016.

The Monopolistic Origins of the EpiPen

The autoinjector known as the EpiPen provides injections of epinephrine in cases of serious or even life-threatening allergy attacks. It is derived from another product known as the Mark I NAAK ComboPen, a device created for a monopoly: the U.S. Military.

In 2007, Mylan “purchased the generic drugs division of Germany’s Merck KGaA for $6.7 billion,” acquiring the EpiPen brand of autoinjectors. Under Merck, the devices cost $7 each, which resulted in just $200 million in gains each year, a mere 5 percent of Merck’s revenue at the time.

But Mylan saw potential in this simple plastic device and focused on how to make the newly purchased brand something that could be widely used. For the dream to come true, Mylan needed the assistance of experts in the monopoly business. That’s when the company turned to the U.S. government for help.

The FDA, Washington, and Crony Capitalism Are All to Blame

Though the EpiPen is not covered by patent protection, Mylan’s close relationship with Washington may have helped the company ensure competition wasn’t an issue.

Jonathan Newman writes that “Mylan has been repeatedly protected from competition, and it has repeatedly (and predictably) increased the price of EpiPens in response.”

For the past seven years, Mylan has been “[turning] to Washington for help. Along with patient groups, Mylan pushed for federal legislation encouraging states to stock epinephrine devices in schools.”

In 2010, when the FDA launched new federal guidelines related to epinephrine prescriptions, Mylan stopped selling single pens, switching to twin-packs. Bloombergreports that, at the time, “35 percent of prescriptions were for single EpiPens,” but as the new rules were implemented, Mylan “changed label rules to allow the devices to be marketed to anyone at risk.” While the guidelines targeted persons who had severe allergic reactions only,

After a seven-year-old died due to an allergic reaction to peanuts at a Virginia school, Congress passed a law pressuring states to ensure its schools had epinephrine devices on hand at all times. The year this bill passed, Mylan spent over $1 million in lobbying alone. Now, Bloomberg reports, “47 states require or encourage schools to stock the devices.”

Over the past seven years, Mylan’s persistence and power-driven attitude helped the company spread the EpiPen far and wide, causing its use to grow 67 percent in the United States. EpiPen prescriptions are now so common that pediatric allergist Robert Wood from Johns Hopkins University School of Medicine says EpiPen is the new “Kleenex.”

But making the EpiPen so popular wasn’t an easy task, mostly because Mylan finally bumped into some competition along the way.

Competition Drives Prices Down — And Mylan Wasn’t Down with That

In 2009, Pfizer Inc., the world’s biggest drugmaker, and Mylan sued Teva Pharmaceutical Industries Ltd. over a patent-infringement. At the time, the Israeli company was accused of using Mylan’s design without permission. But in 2012, both parties reached an agreement, and Teva was allowed to seek approval from the FDA for its epinephrine injecting device.

According to Gizmodo, Teva has failed to obtain approval from the FDA to develop affordable generic versions of the EpiPen. The company says it won’t try to go through the same process again until 2017.

The only other device that was closer to competing with Mylan’s EpiPen was Auvi-Q, and it was also driven out of the market. In 2015, the company launched a recall campaign claiming the devices could be delivering faulty dosages.

“Epinephrine is extremely cheap,” reported Jonathan Newman. In order to understand why Mylan was able to raise the prices of EpiPen, we mustn’t look at the device or drug. We also cannot blame the markets for this issue. Instead, we must look at how Mylan keeps competition at bay.

“Mylan has a great friend who keeps would-be competitors out of the market, or at least makes it so difficult for them that they eventually go out of business.” Mylan’s friend, in this case, is the FDA — a government agency.

Without the ability to pay corporations any favors, Washington power players would not be passing resolutions and pieces of legislation that benefit Mylan.

The current environment favors this influence game played by both government officials and corporate drones, but ultimately, the consumer pays the price. Few members of the mainstream media are taking the time to explain this relationship. Mostly because, they too, are involved in this systemic influence scheme.